This is complete and
utter BS from the
FDA. What they're
doing now to avoid
culpability in this
current case is
crying that they do
not have the
authority to stop
the likes of NECC
and their sister
company Ameridose.
That is just not
true.
The FDA, right now,
has, without a
single new law or
regulation, both the
authority, and the
obligation, to put a
stop to companies
like NECC and
Ameridose. Both
companies are acting
as drug
manufacturers. It
may be true that
sometimes the line
between compounding
and manufacturing is
difficult to
establish, but no
sane person could
look at either of
these companies and
not clearly see on
which side of that
line both fall.
A drug manufacturer
that calls itself a
pharmacy is still a
drug manufacturer,
even if the license
on the wall says
it's a pharmacy.
When you produce
tens of thousands of
doses of drug
product for sale
around the country
to hospitals,
physicians, and
clinics, you are
absolutely,
positively NOT a
pharmacy. And Deb
Autor and everyone
else at the FDA
knows this. In the
interests of the
families of the 14
dead peoople,
Congress needs to
find out from FDA
why they decided to
allow NECC to
continue acting as a
drug manufacturer
when they had the
ability to stop
them..

wulf utian

10/13/12

Read a Primer for Physicians on how to avoid legal exposure if using compounded drugs at:
http://adisonline.com/drugs/Abstract/publishahead/Pharmacy_Compounding_Primer_for_Physicians_.99
874.aspx.

richard hertz

10/13/12

The companies do
indeed use NDC
numbers. At least in
the case of
Ameridose (I'm not
sure about NECC, but
I assume they've
done something
similar), they are
registered with FDA
as a re-packager and
thus got the
manufacturer's code
that makes up the
first section of an
NDC number. Of
course, this is a
farce. Ameridose is
no more a
re-packager than
Baxter is...both
engage in drug
MANUFACTURING..

Dr. Gregory E. Johnson, D. C.

10/13/12

If these compounding "Pharmacies" are making "Drugs" in this particular case, Epidural Steroid
Injectables, why wouldn't they be subject to the same scrutiny that other drug companies are by the FDA?
I believe consumers/patients should be told, via some sort of "Informed Consent", that there are possible
dangerous side effects from these medications, just as other medications are required to publish. Public
safety is and has always been the supposed role of the FDA. On the other hand the FDA has "Approved"
many other drugs as being, "Safe and Effective", then turn right around and take them off the market,
unfortunately after many people have been hurt and/or die as a result of the harmful side effects of
those particular drugs. I have contended for a long time now, that many of the drugs the FDA approves
as being "Safe & Effective" which are not scrutinized properly before being approved in the first place.
Look how many drugs have been approved by the FDA, as "Safe & Effective", when in actuality they are
really unsafe and harmful to the public. The general public deserves to know the truth about what the
dangerous side effects are, before taking medications of any kind, regardless if they come from a big
pharmaceutical company or a compounding pharmacy. I have seen many patients harmed by, "Safe &
Effective" drugs, without knowing the risk, prior to taking them or having them injected into their bodies.
New Federal laws should govern the drug industry as a whole, for the benefit of the public..

richard hertz

10/13/12

@ Dr. Johnson:
"If these
compounding
"Pharmacies" are
making "Drugs" in
this particular
case, Epidural
Steroid Injectables,
why wouldn't they be
subject to the same
scrutiny that other
drug companies are
by the FDA?"
The sad answer is
that companies will
and do break the law
all the time.
They'll try to get
away with whatever
they can get away
with. The legal
reality is that if
any company, whether
it be a pharmacy, a
hospital, or even a
7-11, wants to
"manufacture" (vs.
"compound") a drug
they will need
approval from the
FDA. Without such
approval, any
product they
manufacture and
distribute would be
considered
misbranded and
subject to seizure
by the FDA. What's
even sadder in this
case is that the FDA
clearly knew what
NECC was doing and
had the authority to
stop them and,
therefore, prevent
these 14 deaths..

Dr. Jacob R. Raitt

10/13/12

I took over as acting director of pharmacy services for a pharmacy
where about 40% of their Rx's were compounded. The error rate was
somewhere between 5 and 10%, while doing just under 100 Rx's daily.
My purpose for this company was to increase accuracy,
accountability and portability while dramatically decreasing the
error rate (that rate being calculated with the number of incorrect
Rx's being received by the client). Using all professional
techniques that I knew and could teach, involving an IT department
dedicated to our accuracy, and training a staff to follow written
policies and procedures (lest they be publicly dismissed) the rate
of errors decreased dramatically. After 5 years of refining,
tweaking, altering and improving, we entered a period where there
were no reported errors for a 40 month period, during which time we
filled an average of 1000 Rx's daily, including 350 to 400 being
compounded. I then retired. Do we need or want oversight by any
state or federal agency? Other than regular inspections,
absolutely not. Must we regulate ourselves? Absolutely. The time
has come where pharmacy must always follow the teaching --
"If I
wouldn't give it to my child, I will give it to no one"..

Medman

10/13/12

The difference between compounding and manufacturing is blurry and confusing. It is created by the confusion
between federal and state authority. Regardless of the power struggle, we must come to the conclusion that all
compounding must be regulated by the FDA. The state Boards of Pharmacy today are in pathetic shape today.
They are resource deprived secondary to huge budget cuts in the recent years. Nor do they have the clinical
expertise to manage the process. We must not forget about the families who lost their loved ones because of the
fungal contamination in epidural products. I am urging all of my physician and pharmacist colleagues to come
forward and demand that the compounding pharmacies must come under the FDA jurisdiction. Time is now and
we cannot waste any time..

virgil berry

10/14/12

Congress/FDA does not need to act on this issue. The company policed
itself. What happens when the FDA performs "oversight"? 2012-
GlaxoSmithKline fined $3billion for illegal promotion. 2009-Pfizer $2.3 billion-fraudulent marketing. 2012-Abbott-$1.5 billion-off
label promotion. 2011-Merck-$950 million-fraudulent marketing and
safety claims. 2007-Purdue-$634.5 million-fraudulent safety claims
for oxycontin. 2007-Bristol-Meyer Squibb $515 million-illegal
promotion. 2010-Astra-Zeneca-$520 million--promoting off label use.
Nothing changed, the companies continue what some would call
criminal activity yet the desire now is new laws to punish a
profession. it is utter nonsense..

Herb Gardener

10/14/12

Re: Dr Jacob Raitt's post - After your retirement, without government regulation do you really believe
anyone will continue to be as conscientious as your described actions appear you to have been? If so,
why was there up to a 10% error when you first became acting director of the pharmacy?.

ChasinRabbits

10/18/12

This is a "system's
failure",
specifically a
GOVERNMENT SYSTEMS
FAILURE. FDA and
Massachusetts' state
agencies dropped the
ball on this
company, which had
received warning
letters from FDA
since 2006. The fact
is FDA and the state
failed to enforce
their own regs and
are now trying to
shirk their
culpability. So what
is the government's
solution to this?
Congress will hold
hearings, which will
ultimately result in
MORE regulations FDA
and the state
agencies won't be
able to enforce..

This survey is a poll of those who choose to participate and are, therefore, not valid statistical samples, but rather a snapshot of what your colleagues are thinking.

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